Introduction: Pulsed field ablation (PFA) exploits the delivery of short high-voltage shocks to induce cells death via irreversible electroporation. The therapy offers a potential paradigm shift for catheter ablation of cardiac arrhythmia. We designed an AC-burst generator and therapeutic strategy, based on the existing knowledge between efficacy and safety among different pulses. We performed a proof-of-concept chronic animal trial to test the feasibility and safety of our method and technology. Methods: We employed 6 female swine - weight 53.75 ± 4.77 kg - in this study. With fluoroscopic and electroanatomical mapping assistance, we performed ECG-gated AC-PFA in the following settings: in the left atrium with a decapolar loop catheter with electrodes connected in bipolar fashion; across the interventricular septum applying energy between the distal electrodes of two tip catheters. After procedure and 4-week follow-up, the animals were euthanized, and the hearts were inspected for tissue changes and characterized. We perform finite element method simulation of our AC-PFA scenarios to corroborate our method and better interpret our findings. Results: We applied square, 50% duty cycle, AC bursts of 100 μs duration, 100 kHz internal frequency, 900 V for 60 pulses in the atrium and 1500 V for 120 pulses in the septum. The inter-burst interval was determined by the native heart rhythm - 69 ± 9 bpm. Acute changes in the atrial and ventricular electrograms were immediately visible at the sites of AC-PFA - signals were elongated and reduced in amplitude (p < 0.0001) and tissue impedance dropped (p = 0.011). No adverse event (e.g., esophageal temperature rises or gas bubble streams) was observed - while twitching was avoided by addition of electrosurgical return electrodes. The implemented numerical simulations confirmed the non-thermal nature of our AC-PFA and provided specific information on the estimated treated area and need of pulse trains. The postmortem chest inspection showed no peripheral damage, but epicardial and endocardial discolorations at sites of ablation. T1-weighted scans revealed specific tissue changes in atria and ventricles, confirmed to be fibrotic scars via trichrome staining. We found isolated, transmural and continuous scars. A surviving cardiomyocyte core was visible in basal ventricular lesions. Conclusion: We proved that our method and technology of AC-PFA is feasible and safe for atrial and ventricular myocardial ablation, supporting their systematic investigation into effectiveness evaluation for the treatment of cardiac arrhythmia. Further optimization, with energy titration or longer follow-up, is required for a robust atrial and ventricular AC-PFA.

Department of Power Electrical and Electronic Engineering Faculty of Electrical Engineering and Communication Brno University of Technology Brno Czechia

Faculty of Veterinary Medicine University of Veterinary and Pharmaceutical Sciences Brno Czechia

Institute of Scientific Instruments of the Czech Academy of Sciences Brno Czechia

International Clinical Research Center St Anne's University Hospital Brno Brno Czechia

International Clinical Research Center St Anne's University Hospital Brno Brno Czechia 1st Department of Internal Medicine Cardioangiology St Anne's University Hospital Masaryk University Brno Czechia

International Clinical Research Center St Anne's University Hospital Brno Brno Czechia Department of Biology Faculty of Medicine Masaryk University Brno Czechia

International Clinical Research Center St Anne's University Hospital Brno Brno Czechia Department of Biology Faculty of Medicine Masaryk University Brno Czechia 1st Department of Internal Medicine Cardioangiology St Anne's University Hospital Masaryk University Brno Czechia

International Clinical Research Center St Anne's University Hospital Brno Brno Czechia Department of Cardiology and Structural Heart Diseases Medical University of Silesia Katowice Poland

International Clinical Research Center St Anne's University Hospital Brno Brno Czechia Department of Histology and Embryology Faculty of Medicine Masaryk University Brno Czechia

International Clinical Research Center St Anne's University Hospital Brno Brno Czechia Department of Power Electrical and Electronic Engineering Faculty of Electrical Engineering and Communication Brno University of Technology Brno Czechia

International Clinical Research Center St Anne's University Hospital Brno Brno Czechia IHU LIRYC Electrophysiology and Heart Modeling Institute Fondation Bordeaux Université Pessac France Univ Bordeaux INSERM UMR 1045 Cardiothoracic Research Center of Bordeaux Pessac France

R and D EP Systems and Sensors BIOTRONIK SE and Co KG Berlin Germany

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